Type 2 DiabetesNCT02701569
Effect of Rebound Exercise in Individuals With Type 2 Diabetes
A study testing Rebound exercise in people with Type 2 Diabetes, run by University of KwaZulu.
Trial summary
The purpose of this study was to investigate the effect of rebound exercise (mini trampoline jumping) on metabolic outcomes and quality of life in patients with Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Rebound exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 30- to 60-year-old male and female individuals;
- A diagnosis of type 2 diabetes ≤ 5 years;
- Attendance at the Diabetes Outpatient Clinics of Aminu Kano Teaching Hospital and Murtala Muhammad Specialist Hospital in Kano, Northwestern Nigeria;
- Self-ambulatory;
- An inactive lifestyle over the last year.
Who cannot join
- A diagnosis of type 2 diabetes for more than 5 years;
- Hypertension (systolic and diastolic blood pressure more than 140 and 90 mmHg, respectively) or treatment for hypertension;
- Use of insulin therapy
- Lower limb weakness and/or deformities with loss of protective sensation in the feet;
- Back, shoulder or knee problems and/or joint instability;
- History of coronary artery disease, retinopathy and nephropathy;
- Myocardial infarction, cardiac or abdominal surgery within the previous 6 months;
- History of fractures of the spine, hip, knee and/or ankle joints.
About this study
Official title: Effect of Rebound Therapy on Metabolic Outcomes and Quality of Life in Nigerian Patients With Type 2 Diabetes
The purpose of this study was to investigate the effect of rebound exercise (mini trampoline jumping) on metabolic outcomes and quality of life in patients with Type 2 Diabetes.
Read the detailed description
The exercise involved jumping on the mini trampoline with feet slightly apart. Participants stood on the mid portion of the trampoline bed and made repeated up-and-down bouncy movements. Each foot strike equals one step or bounce. With each landing, the mat of the trampoline underwent deformation and the springs released the energy stored in them such that the participant was made to bounce off the mat. Exercise was administered for between 10 - 15 minutes after which a 5-minute period of rest was allowed. A heart rate monitor was used to guide the intensity of the exercise in the moderate range. Each participant accumulated between 20 and 30 minutes of rebound exercise (bouncing on a mini trampoline) per session, administered three times per week for 12 weeks. All data were captured at baseline and at the end of the 12-week intervention period.
- Conditions
- Type 2 Diabetes
- Being tested
- Rebound exercise
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebound exerciseOther
Also called Mini trampoline rebounding
Repeated jumping on a mini trampoline was administered
| Study group | Role | What they receive |
|---|---|---|
| Rebound exercise | Experimental | Repeated jumping on a mini trampoline was performed with feet slightly apart Receives: Other: Rebound exercise |
| Control | No intervention | No exercise was administered but participants continued with routine medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin
Glycated hemoglobin was assessed using the mini-column ion-exchange chromatographic method and expressed in percentage
Measured: 3 months
Secondary outcomes (16)
Fasting plasma glucose
Fasting plasma glucose (in molar concentration) was measured by glucose oxidase assay using a glucose analyzer
Measured: 3 months
Fasting insulin
Fasting insulin (in gravimetric unit) was determined using a commercially available ELISA human insulin kit
Measured: 3 months
High-density lipoprotein cholesterol
High-density lipoprotein cholesterol (in molar concentration) was enzymatically determined using commercial kits
Measured: 3 months
Total cholesterol
Total cholesterol (in molar concentration) was enzymatically determined using commercial kits
Measured: 3 months
Triglycerides
Triglycerides (in molar concentration) were enzymatically determined using commercial kits
Measured: 3 months
Low-density lipoprotein cholesterol
Low-density lipoprotein cholesterol (in molar concentration) was estimated using the Friedewald formula.
Measured: 3 months
Quality of life
The short-form 36 health questionnaire was used to assess participants' quality of life and expressed in percentage
Measured: 3 months
Body mass
Body mass in kilograms was determined using a calibrated weighing scale
Measured: 3 months
Height
Height in meters was determined using a stadiometer
Measured: 3 months
Heart rate
Heart rate was measured in beats per minute using a calibrated electronic device
Measured: 3 months
Respiratory rate
Respiratory rate (in cycles per minute) was measured by observing and counting the number of times the chest rose in one minute
Measured: 3 months
Blood pressure
Blood pressure in millimeters of mercury (mmHg) was measured using a calibrated electronic device
Measured: 3 months
Maximal oxygen consumption
Maximal oxygen consumption in milliliters per kilogram per minute (ml/kg/min) was obtained from exercise stress testing
Measured: 3 months
Diabetes-related emotional distress as measured by the Problem Areas in Diabetes Scale
Diabetes-related emotional distress was expressed in percentage
Measured: 3 months
Well-Being as measured by the World Health Organization-Well-Being Index
Participants' well-being was expressed in percentage
Measured: 3 months
Treatment satisfaction as measured by the World Health Organization-Diabetes Treatment Satisfaction Questionnaire
Score ranges from 0 (very dissatisfied) to 36 (very satisfied)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of KwaZulu
- Sponsor type
- University, hospital or other
- Collaborators
- Aminu Kano Teaching Hospital
- Responsible party
- Sponsor
- Investigators
- Sonill S Maharaj, PhD, Study chair, UKZN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701569
- Sponsor's protocol ID
- BF389/13
- Status last verified
- Feb 2016
- First submitted
- 17 Feb 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data would not be shared
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rebound Therapy on Metabolic Outcomes and Quality of Life in Nigerian Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02701569
- Acronym / sponsor ID
- BF389/13
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of KwaZuluUniversity, hospital or other
- Collaborators
- Aminu Kano Teaching Hospital
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to investigate the effect of rebound exercise (mini trampoline jumping) on metabolic outcomes and quality of life in patients with Type 2 Diabetes.
Detailed description
The exercise involved jumping on the mini trampoline with feet slightly apart. Participants stood on the mid portion of the trampoline bed and made repeated up-and-down bouncy movements. Each foot strike equals one step or bounce. With each landing, the mat of the trampoline underwent deformation and the springs released the energy stored in them such that the participant was made to bounce off the mat. Exercise was administered for between 10 - 15 minutes after which a 5-minute period of rest was allowed. A heart rate monitor was used to guide the intensity of the exercise in the moderate range. Each participant accumulated between 20 and 30 minutes of rebound exercise (bouncing on a mini trampoline) per session, administered three times per week for 12 weeks. All data were captured at baseline and at the end of the 12-week intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rebound exercise | Experimental | Other: Rebound exerciseRepeated jumping on a mini trampoline was performed with feet slightly apart |
| Control | No intervention | –No exercise was administered but participants continued with routine medical care |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 30- to 60-year-old male and female individuals;
- A diagnosis of type 2 diabetes ≤ 5 years;
- Attendance at the Diabetes Outpatient Clinics of Aminu Kano Teaching Hospital and Murtala Muhammad Specialist Hospital in Kano, Northwestern Nigeria;
- Self-ambulatory;
- An inactive lifestyle over the last year.
Key exclusion criteria (8 listed)
- A diagnosis of type 2 diabetes for more than 5 years;
- Hypertension (systolic and diastolic blood pressure more than 140 and 90 mmHg, respectively) or treatment for hypertension;
- Use of insulin therapy
- Lower limb weakness and/or deformities with loss of protective sensation in the feet;
- Back, shoulder or knee problems and/or joint instability;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rebound exerciseAlso: Mini trampoline reboundingRepeated jumping on a mini trampoline was administered | Other | Rebound exercise |
Primary outcome
Glycated hemoglobin
Time frame: 3 months
Glycated hemoglobin was assessed using the mini-column ion-exchange chromatographic method and expressed in percentage
16 secondary outcomes
Fasting plasma glucose
Time frame: 3 months
Fasting insulin
Time frame: 3 months
High-density lipoprotein cholesterol
Time frame: 3 months
Total cholesterol
Time frame: 3 months
Triglycerides
Time frame: 3 months
Low-density lipoprotein cholesterol
Time frame: 3 months
Quality of life
Time frame: 3 months
Body mass
Time frame: 3 months
Height
Time frame: 3 months
Heart rate
Time frame: 3 months
Respiratory rate
Time frame: 3 months
Blood pressure
Time frame: 3 months
Maximal oxygen consumption
Time frame: 3 months
Diabetes-related emotional distress as measured by the Problem Areas in Diabetes Scale
Time frame: 3 months
Well-Being as measured by the World Health Organization-Well-Being Index
Time frame: 3 months
Treatment satisfaction as measured by the World Health Organization-Diabetes Treatment Satisfaction Questionnaire
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Individual participant dataSharing planned: No. Data would not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonill S Maharaj, PhD study chair
UKZN
Questions about this trial
What is this clinical trial studying?
A study testing Rebound exercise in people with Type 2 Diabetes, run by University of KwaZulu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.